Magnetic-resonance imaging (“magnetic-resonance imaging”) has been developed as an imaging technique adapted to obtain both images of anatomical features of human patients as well as some aspects of the functional activities of biological tissue. These images have medical diagnostic value in determining the state of the health of the tissue examined.
In a magnetic-resonance imaging process, a patient is typically aligned to place the portion of the patient's anatomy to be examined in the imaging volume of the magnetic-resonance imaging apparatus. Such an magnetic-resonance imaging apparatus typically comprises a primary magnet for supplying a constant magnetic field (B0) which, by convention, is along the z-axis and is substantially homogeneous over the imaging volume and secondary magnets that can provide linear magnetic field gradients along each of three principal Cartesian axes in space (generally x, y, and z, or x1, x2 and x3, respectively). The apparatus also comprises one or more radio-frequency coils that provide excitation and detection of the magnetic-resonance imaging signal.
The use of the magnetic-resonance imaging process with patients who have implanted or non-implanted medical assist devices; such as, but not limited to, cardiac assist devices, implanted insulin pumps, catheter guide wires, leads for neurostimulation probes, intraluminal coils, guided catheters, temporary cardiac pacemakers, temporary esophageal pacemakers; often presents problems.
For a specific example, as is known to those skilled in the art, implantable devices (such as implantable pulse generators (IPGs) and cardioverter/defibrillator/pacemakers (CDPs)) are sensitive to a variety of forms of electromagnetic interference (EMI) because these enumerated devices include sensing and logic systems that respond to low-level electrical signals emanating from the monitored tissue region of the patient and that these devices may also have metal wire leads, which can act as antenna and provide a path for the induced energy to travel to and possibly damage power sensitive circuitry.
Since the sensing systems and conductive elements of these medical assist devices are responsive to changes in local electromagnetic fields, the medical assist devices are vulnerable to external sources of severe electromagnetic noise, and in particular, to electromagnetic fields emitted during the magnetic-resonance imaging (magnetic-resonance imaging) procedure. Thus, patients with medical assist devices are generally advised not to undergo magnetic-resonance imaging (magnetic-resonance imaging) procedures.
To more appreciate the problem using a specific illustration, namely the use of implantable cardiac assist devices during a magnetic-resonance imaging process, will be briefly discussed.
The human heart may suffer from two classes of rhythmic disorders or arrhythmias: bradycardia and tachyarrhythmia. Bradycardia occurs when the heart beats too slowly, and may be treated by a common implantable pacemaker delivering low voltage (about 3 V) pacing pulses.
The common implantable pacemaker is usually contained within a hermetically sealed enclosure, in order to protect the operational components of the device from the aqueous environment of the body, as well as to protect the body from the device.
The common implantable pacemaker operates in conjunction with one or more electrically conductive leads, adapted to conduct electrical stimulating pulses to sites within the patient's heart and to communicate sensed signals from those sites back to the implanted device.
Furthermore, the common implantable pacemaker typically has a metal case and a connector block mounted to the metal case that includes receptacles for leads which may be used for electrical stimulation or which may be used for sensing of physiological signals. The battery and the circuitry associated with the common implantable pacemaker are hermetically sealed within the case. Electrical interfaces are employed to connect the leads outside the metal case with the medical device circuitry and the battery inside the metal case.
Electrical interfaces serve the purpose of providing an electrical circuit path extending from the interior of a hermetically sealed metal case to an external point outside the case while maintaining the hermetic seal of the case. A conductive path is provided through the interface by a conductive pin that is electrically insulated from the case itself.
Such interfaces typically include a ferrule that permits attachment of the interface to the case, the conductive pin, and a hermetic glass or ceramic seal that supports the pin within the ferrule and isolates the pin from the metal case.
A common implantable pacemaker can, under some circumstances, be susceptible to electrical interference such that the desired functionality of the pacemaker is impaired. For example, common implantable pacemaker requires protection against electrical interference from electromagnetic interference (EMI), defibrillation pulses, electrostatic discharge, or other generally large voltages or currents generated by other devices external to the medical device. As noted above, more recently, it has become crucial that cardiac assist systems be protected from magnetic-resonance imaging sources.
Such electrical interference can damage the circuitry of the cardiac assist systems or cause interference in the proper operation or functionality of the cardiac assist systems. For example, damage may occur due to high voltages or excessive currents introduced into the cardiac assist system by voltages or currents induced in the cardiac assist system circuitry or on the wire leads leading to and from the cardiac assist system circuitry.
Therefore, it is required that such voltages and currents be limited at the input of such cardiac assist systems, e.g., at the interface. Protection from such voltages and currents has typically been provided at the input of a cardiac assist system by the use of one or more zener diodes and one or more filter capacitors.
For example, one or more zener diodes may be connected between the circuitry to be protected, e.g., pacemaker circuitry, and the metal case of the medical device in a manner which grounds voltage surges and current surges through the diode(s). Such zener diodes and capacitors used for such applications may be in the form of discrete components mounted relative to circuitry at the input of a connector block where various leads are connected to the implantable medical device, e.g., at the interfaces for such leads.
However, such protection, provided by zener diodes and capacitors placed at the input of the medical device, increases the congestion of the medical device circuits, at least one zener diode and one capacitor per input/output connection or interface. This is contrary to the desire for increased miniaturization of implantable medical devices.
Further, when such protection is provided, interconnect wire length for connecting such protection circuitry and pins of the interfaces to the medical device circuitry that performs desired functions for the medical device tends to be undesirably long. The excessive wire length may lead to signal loss and undesirable inductive effects. The wire length can also act as an antenna that conducts undesirable electrical interference signals to sensitive CMOS circuits within the medical device to be protected.
Additionally, the radio frequency (radio-frequency) energy that is inductively coupled into the wire causes intense heating along the length of the wire, and at the electrodes that are attached to the heart wall. This heating may be sufficient to ablate the interior surface of the blood vessel through which the wire lead is placed, and may be sufficient to cause scarring at the point where the electrodes contact the heart. A further result of this ablation and scarring is that the sensitive node that the electrode is intended to pace with low voltage signals becomes desensitized, so that pacing the patient's heart becomes less reliable, and in some cases fails altogether. Additionally, the switching of the gradient magnetic fields may also induce unwanted voltages causing problems with the circuitry and potential pacing of the heart.
Another conventional solution for protecting the implantable medical device from electromagnetic interference is illustrated in FIG. 1. FIG. 1 is a schematic view of an implantable medical device 12 embodying protection against electrical interference. At least one lead 14 is connected to the implantable medical device 12 in connector block region 13 using an interface.
In the case where implantable medical device 12 is a pacemaker implanted in a body 10, the pacemaker 12 includes at least one or both of pacing and sensing leads represented generally as leads 14 to sense electrical signals attendant to the depolarization and repolarization of the heart 16, and to provide pacing pulses for causing depolarization of cardiac tissue in the vicinity of the distal ends thereof.
FIG. 2 more particularly illustrates the circuit that is used conventionally to protect from electromagnetic interference. As shown in FIG. 2, protection circuitry 15 is provided using a diode array component 30. The diode array consists of five zener diode triggered semiconductor controlled rectifiers (SCRs) with anti-parallel diodes arranged in an array with one common connection. This allows for a small footprint despite the large currents that may be carried through the device during defibrillation, e.g., 10 amps. The SCRs 20-24 turn on and limit the voltage across the device when excessive voltage and current surges occur.
Some of the zener diode triggered SCRs may be connected to an electrically conductive pin, with each electrically conductive pin being connected to a medical device contact region to be wire bonded to pads of a printed circuit board. The diode array component 30 of FIG. 2 may be connected to the electrically conductive pins via die contact regions along with other electrical conductive traces of the printed circuit board.
Other attempts have been made to protect medical assist devices from magnetic-resonance imaging fields. For example, U.S. Pat. No. 5,968,083 (to Ciciarelli et al.) describes a device adapted to switch between low and high impedance modes of operation in response to EMI insult. Furthermore, U.S. Pat. No. 6,188,926 (to Vock) discloses a control unit for adjusting a cardiac pacing rate of a pacing unit to an interference backup rate when heart activity cannot be sensed due to EMI.
Another problem associated with magnetic-resonance imaging is the temperature change in tissue regions caused by using conventional magnetic-resonance imaging techniques. When a substance such as human tissue is subjected to a static magnetic field, the individual magnetic moments of the spins in the tissue align in a parallel and anti-parallel direction with the static magnetic field. This direction along the static magnetic field can be termed as the longitudinal direction. In magnetic-resonance imaging, the radio frequency polarizing field used for spin manipulation is constantly changing and thus, the individual magnetic moments of the spins in the tissue attempt to align with the polarizing field. The constant changing of alignment of the magnetic moments of the spins in the tissue causes the tissue's temperature to increase, thereby exposing the tissue to possible magnetic-resonance imaging induced thermal damage.
Although, conventional medical assist devices provide some means for protection against electromagnetic interference, these conventional medical assist devices require much circuitry and fail to provide fail-safe protection against radiation produced by magnetic-resonance imaging procedures. Moreover, the conventional medical assist devices fail to address the possible damage that can be done at the tissue interface due to radio-frequency-induced heating. Furthermore, the conventional medical assist devices fail to address the unwanted tissue region stimulation that may result from radio-frequency-induced electrical currents. Lastly, conventional magnetic-resonance imaging processes fail to provide a proper safeguard against potential magnetic-resonance imaging induced thermal damage due to the tissue's exposure to the switching magnetic field gradients and the circularly polarized Radio Frequency Field of the magnetic-resonance imaging process.
Thus, it is desirable to provide protection against electromagnetic interference, without requiring much circuitry and to provide fail-safe protection against radiation produced by magnetic-resonance imaging procedures. Moreover, it is desirable to provide medical assist devices that prevent the possible tissue damage that can be done at the tissue interface due to induced electrical signals. Furthermore, it is desirable to provide an effective means for transferring energy from one point in the body to another point without having the energy causing a detrimental effect upon the body. Lastly, it is desirable to implement a magnetic-resonance imaging process, which can be modified, automatically or manually, in response to sensed tissue temperature changes or known localized specific energy absorption rates, so as to prevent possible magnetic-resonance imaging induced thermal damage.